Drug application
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (HOMATROPINE METHYLBROMIDE, HYDROCODONE BITARTRATE)
Drugs@FDA ANDA 203535 · NOVEL LABS INC
Key facts
| Drug name | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE |
|---|---|
| Active ingredients | HOMATROPINE METHYLBROMIDE, HYDROCODONE BITARTRATE |
| Application type | ANDA |
| Application number | 203535 |
| Company | NOVEL LABS INC |
| Dosage forms | SYRUP, ORAL |
| Strength | 1.5MG/5ML;5MG/5ML |
| Marketing status | Prescription |
| TE codes | AA |
| Reference listed drug | No |
| Latest submission status date | Feb 13, 2017 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.